Senior Officer

2 weeks ago

Mumbai, Maharashtra, India Harman Finochem Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Dear Candidates,

We are hiring for Sr. Officer / Executive - Regulatory Affairs - API Pharma for Mumbai location:

Role & responsibilities :

  1. Compilation and submission of Drug Master File (DMF) to USFDA, EDQM, Health Canada, Australia, China, Japan, Brazil and for EU countries

  2. Submission of DMF amendments and variation filings to implement the post approval changes.

  3. Evaluation of change controls and perform regulatory assessment based on submitted DMF.

  4. Co-ordinated with cross functional team such as QA, QC, Production, ADL and R&D and review of documents received for registration purpose.

  5. To Maintain regulatory database by following best regulatory practices.

  6. To prepare action plan for Deficiency letter response and timely Respond to deficiency letters.
  7. To provide best in class, API regulatory support to Customers.
  8. Knowledge of current regulatory guidelines and ICH guidelines.

Preferred candidate profile :

Educational Qualification: B.Sc/ M.Sc./ BPharma

Candidate with minimum 3-6 years of experience in Regulatory affairs API

Job location: Kalina, Santacruz (East) / Kurla (West)

Interested candidates can share their CVs at

Please Note: Only candidates with relevant API regulatory experience will be considered

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